Medical Device

Porzio New England Healthcare Compliance Roundtable: Compliance Measurements

4/7/2017| Event

We are pleased to begin the third year of the Porzio New England Healthcare Compliance Roundtables, presented by Porzio Life Sciences. We anticipate another great series of discussions on important topics for those who have compliance responsibilities in the ever-changing medical device industry. 

The spring event, "Compliance Measurements," took place on April 7, 2017 at the Westin Waltham.

Topics included:

  • Roundtable attendees' views/uses of the measurement options: auditing v. monitoring v. business analytics/metrics; 
  • Why we love numbers, or what numbers can do for us; 
  • Determining what you want to know and how you might get at it… and what you will do with what you learn (The Plan); 
  • Accessing the easy data for the most risky areas first; where to look; 
  • Finding allies; 
  • Testing your approach before implementing it; 
  • Avoiding/Overcoming the pitfalls associated with measuring compliance activities/performance; how the numbers can fail us; and
  • Getting comfortable with the treasure trove of data/metrics: The annual business planning process.

This complimentary program is intended for employees of medical device companies who have compliance responsibilities.

As in the past, Porzio will organize the discussion but the Roundtable participants will guide where we go with the conversation. Porzio will provide benchmarking information when appropriate. We will save some time at the end of the agenda for "hot topics" the attendees would like to review.

Agenda:

 7:45 AM: Buffet Breakfast
 8:30 AM: Introductions
 8:40 AM: Compliance Measurements
10:15 AM: Break
10:30 AM: Attendees' Hot Topics
11:20 AM: Wrap-up
11:30 AM: Adjourn

This event is complimentary but registration is required. To register, please click here

2016 PorzioLS Year-End Report: The Ever-Changing World of Life Sciences

2/24/2017| News

Porzio Life Sciences ("PorzioLS") has been a leading resource for the life sciences industry for over 12 years. As such, the company has been front and center for the exciting changes that continue to drive the evolution of the industry. Porzio proudly offers the 2016 Porzio Life Sciences Year-End Report as an overview of many of the year’s key events.

Topics include:

  • Licensing and Distribution
    • Drug Stewardship Programs
    • New Massachusetts Legislation
    • Implementing the Drug Supply Chain Security Act
    • Making Moves: Update on Third-Party Logistics Provider Licensing
    • The Logistics: Key Changes
    • New Jersey Enacts Legislation Clarifying Licensing Requirements
    • New Jersey Proposes Legislation to Restrict the Provision of Discounts, Rebates, or Product Vouchers
  • Enforcement Actions
    • PhRMA and BIO Published Principles of Off-Label Communication
    • FDA Public Hearing on Off-Label Communication
    • OIG Final Rules on Anti-Kickback Safe Harbors and Civil Monetary Penalties
    • FDA’s Office of Prescription Drug Promotion
  • International Transparency
    • A Milestone Moment for the Global Transparency Movement
    • EFPIA 2016 Overall Total Spend by Country
    • 2017 Projected Reporting Dates by Country
    • Porzio GST
  • Mid-Level Regulations
    • Key Changes for Mid-Level Professionals
  • U.S. Transparency and Limitations
    • Sunshine Act Statistics: 2015 Open Payments Data
    • Price and Cost Transparency
    • Chicago Adopts Licensing Ordinance for Pharmaceutical Representatives
    • The New Kid on the Block: The First Disclosure Reports for Connecticut Will Be Filed in 2017
    • D.C. Introduces Temporary and Emergency Legislation to Amend the Pharmaceutical Detailer Licensure Exemption

 

 

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Porzio's Class Action and Life Sciences Practices Recognized by the Global Law Experts Awards

6/28/2016| News

Porzio, Bromberg & Newman, P.C. (Porzio) has been recognized by Global Law Experts (GLE) in two practice areas, for the 7th Annual Global Law Experts Awards:

  • Winner, Readers Choice category: Class Actions Law Firm of the Year in New Jersey, 2016
  • Winner: Life Sciences Law Firm of the Year in New Jersey, 2016

The Porzio Class Action Defense Group has years of experience defending class action cases as primary counsel or as the local counsel member of national defense teams. Our extensive history handling federal and state cases enables us to develop key strategies to defeat certification and defend the underlying case while, when appropriate, creatively devising mediation and settlement strategies. 

The Porzio Life Sciences Group draws upon our wealth of experience to help life sciences companies navigate the complex and ever-changing compliance landscape. Porzio provides a wide array of compliance and regulatory counseling services to pharmaceutical, medical device, and biotech companies at every stage of development, including: counseling clients on anti-kickback considerations and compliance with industry standards; developing compliance manuals, policies, and standard operating procedures; preparing audits, gap analyses, and risk assessments of companies’ compliance policies; and serving as members of promotional review teams, among countless other services.

GLE is an online resource that assists businesses, investors and individuals in locating legal counsel in a variety of practice areas. The Global Law Experts Awards were established in 2010. Over 120,000 recommendations have been received from business leaders, in-house legal counsel, bar associations and others in the legal community. Recommended law firms were judged on client testimonials, key cases, publication and speaking engagement contributions, and the reputation of individual team attorneys.

To learn more about the Global Law Experts Awards methodology, visit Global Law Experts Awards

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